Light Therapy to Improve Sleep in TBI: Sleep-active Biomarkers and Glymphatic Function (NCT07601841) | Clinical Trial Compass
RecruitingNot Applicable
Light Therapy to Improve Sleep in TBI: Sleep-active Biomarkers and Glymphatic Function
United States300 participantsStarted 2025-12-12
Plain-language summary
This is a clinical trial designed to examine how improved sleep through morning bright light therapy is improving downstream key physiologic processes related to brain health, i.e., mitochondrial function, systemic inflammation, and glymphatic function. All proposed methodology is already approved in other IRB applications.
Who can participate
Age range
18 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
All subjects must:
1. Male and female; any race; 18-89 years of age.
2. Be English speaking.\*
3. Be accessible via phone.
4. Be non-decisionally impaired. Determined by assessing the subject's ability to verbalize their understanding of the protocol back to us during the informed consent process.
5. Not have a history of macular degeneration.
6. Not have a history of bipolar disorder.
7. Not be currently using a lightbox or a negative ion generator.
8. Not be a shift worker.
9. Have a documented history of TBI via the Head Trauma Events Characteristics (HTEC) or OHIO conducted in accordance with VA/DoD Clinical Practice Guidelines.88
10. Present with self-reported sleep-wake disturbances.
11. Remain clinically stable for current pharmacologic treatment related to depression/anxiety, sleep, and pain.
12. MRI specific compatibility requirements:
* No pacemaker, wires, defribrillator or implanted heart valves
* No history of head surgery requiring aneurysm clips
* No history of other orthopedic or general surgery requiring the implantation of ferrous pins, joints, electric devices/pumps, or other foreign metal objects
* History of eye exposure to metal (unprotected welding/metalworking/shrapnel) is allowable provided the participant screens negative for metal in the eyes on an orbital x-ray or is able to provide clinical documentation of having screened negative.
* No history of non-removable hearing aids, middle/inner ear prosthesis, or dentures
* No …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Define the profile of blood-based markers of systemic inflammation pre- vs post-MBLT.
Timeframe: From pre-intervention to end of device use (Approximately 4 weeks).
2
Define mitochondrial function (oxygen consumption rate via Seahorse) pre- vs. post-MBLT.
Timeframe: From pre-intervention to end of device use (Approximately 4 weeks).
3
Explore glymphatic function via novel multi-model non-contrast-based MRI pre- vs. post-MBLT.
Timeframe: From pre-intervention to end of device use (Approximately 4 weeks).